Transfer device

Abstract

To provide a transfer device for withdrawal or delivery of a medium out of or into a bottle with a neck, which is sealable by a closure.SOLUTION: The present invention relates to a transfer device 10 for removing or transferring a medium out of or into a bottle 20 having a bottle neck 34 that can be sealed by means of a closure, including a first adapter part 12, which can be positioned on the bottle, and a second adapter part 14, which interacts with the first adapter part, which can be displaced in the longitudinal direction of the bottle, and has a conducting element 50 for piercing the closure, wherein after the second adapter part has been displaced along the first adapter part in the direction of the closure and the second adapter part has been locked, the first adapter part is non-releasably fastened to or around the bottle.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The present invention relates to a first adapter part that can be positioned on a bottle, a second adapter part that interacts with the first adapter part and is movable in the longitudinal direction of the bottle and has a transfer element such as a needle, cannula, spike, or piercing device for piercing through a sealing plug, a transfer device for removing or transferring a medium from or to a bottle having a neck of the bottle that can be sealed through a sealing plug.

Background Art

[0002] A number of drugs for infusion, injection, or drip infusion are supplied as dry substances and are only mixed with water or other solvents for dissolution or suspension for the first time immediately before use / administration. Other liquid formulations have to be diluted before use.

[0003] In that case, the dry substances are generally supplied in infusion bottles, so-called vial bottles. The first liquid drugs are also provided in vial bottles. To connect this bottle to another container or infusion device, a connector (transfer device) that is inserted into the head of the vial bottle to make a hole in the film of the vial bottle can be used. In that case, the other container can be, for example, another infusion bottle, infusion bag, solvent bag, or syringe.

[0004] Based on the prior art, these connectors, also called adapters and composed of adapter parts, can comprise a central steel cannula or plastic mandrel, which is surrounded by a collar that forms a hollow cylinder, and the collar snaps shut a flange cap of the vial bottle, especially made of aluminum, at its peripherally formed flange. A piercing needle, especially in the shape of a steel cannula, protrudes from the bottom wall of the collar and extends in the longitudinal direction of the hollow cylinder.

[0005] This type of adapter no longer meets the requirements of the latest vial adapters, and more specifically, for many reasons.

[0006] Based on regulations such as the Technical Rules of Federal Administrative Agencies on Hazardous Substances in Public Health Work (TRGS525) and Occupational Medicine in Public Health Work (M620) of the Professional Association for Public Health and Social Welfare Work (Public Health Work), the release of hazardous substances, such as pharmaceutical substances, must be avoided in principle and preferably reduced. This is especially important when compounding hazardous substances with pharmaceutical substances.

[0007] Employees, patients, and the environment are exposed to such releases. Absorption of the released substances is possible through inhalation, skin, and mouth. The releases themselves can occur, for example, through the formation of aerosols, the formation of splashes during preparation, leakage from adapters when adapters are removed, possibly through glass breakage, and injury from contaminated cannulas.

[0008] On the other hand, conventional vial adapters known in the prior art are basically used without aerosol airtightness or leak airtightness.

[0009] On the other hand, safety measures against injuries from contaminated needles are not provided as required by the accident prevention regulation TRBA250 (Technical Regulations on Biological Work Substances). Similarly, exposure due to adapter removal is not prevented.

[0010] The second reason is that, in order to ensure a leak-proof connection for the vial, the seal must be punctured centrally by the puncture needle. However, in vial adapters used based on conventional technology, there is a risk that the vial will tilt within the collar when it is clicked shut. This results in the initial eccentric puncture of the seal. Then, during the subsequent full push-in of the vial, the cannula is forced into a central position. This puts stress on the vial's seal, potentially leading to leakage from the side of the cannula. This could endanger employees and patients, for example, with toxic substances such as cell proliferation inhibitors.

[0011] Regardless of this, the corresponding adapters do not fundamentally provide airtightness against aerosols and leaks.

[0012] The transfer device according to Patent Document 1 consists of a cap-shaped external guide component and a tubular internal guide component that are movable relative to each other in a telescope-like manner. In the unused state, the internal guide component is initially engaged with a notch that extends inward into the external guide component. When the transfer device is pushed into a vial, a tongue-shaped element extending from the internal guide component is bent outward, and as a result the external guide component is repositioned outward in the area of ​​the notch, thereby releasing the lock between the internal and external guide components. A drawback is that the transfer device can be easily pulled away from the vial after use, which may create a new risk of injury to the user.

[0013] Patent Document 2 provides a transfer device that includes a needle holder having a transfer needle that can change position in the axial direction in a hollow cylindrical structure. This structure includes a wall-shaped stopper that can be attached to the opening of a storage container to be pierced and is pierced by the transfer needle when the transfer device is operated.

[0014] The transfer device according to Patent Document 3 includes an operating unit that can change the axial position of a first component equipped with a mandrel relative to a second component surrounding the sealing stopper of a bottle.

[0015] Patent Document 2 describes a fluid transfer device including a sleeve-shaped guide structure having a needle holder with a puncture needle surrounded thereby. The sleeve-shaped guide structure comprises a movable sleeve band that extends axially based on one embodiment, the sleeve band comprising a clamping element for gripping the bulging periphery of a vial.

[0016] The transfer device according to Patent Document 4 comprises internal and external adapter components welded using ultrasonic waves in a flange-shaped peripheral region. The transfer device surrounds a vial bottle whose sides are surrounded by a cover that engages with the transfer device.

[0017] This design also has the drawback of allowing for easy release from the vial after the transfer device has been used.

[0018] Furthermore, the separability of the vial and connector presents a drawback: the risk of contamination, for example, through aspiration, skin contact, or aerosol formation during needle removal from the vial. [Prior art documents] [Patent Documents]

[0019] [Patent Document 1] EP1430864B1 [Patent Document 2] DE102005006771A1 [Patent Document 3] DE69808432T2 [Patent Document 4] WO2009 / 029390A1 [Overview of the project]

[0020] The object of the present invention is particularly based on providing a transfer device, namely a vial connector or vial adapter, that provides enhanced exposure safety.

[0021] From another perspective, in some cases, it must be ensured that aerosol tightness is already obtained during the puncture of the vial, i.e., the bottle.

[0022] One perspective aims to prevent dangerous leaks after piercing the sealing plug.

[0023] Another important perspective is that the aerosol generated by the separation process does not leak out by the adapter staying on or around the vial. Also, the adapter must provide aerosol tightness during use.

[0024] Another perspective of the present invention is that injuries after the use of a transfer device by transfer elements such as needles, cannulas, spikes, piercing devices are eliminated.

[0025] To solve one or more perspectives, the present invention particularly anticipates that the first adapter part is irreversibly fixed to or around the bottle based on the movement of the second adapter part along the first adapter part in the direction of the sealing plug and the engagement of the second adapter part.

[0026] In that case, a fixing element that can be particularly radially repositioned can emerge from the first adapter part, through which the first adapter part is irreversibly fixed to the bottle in the proper operation of the transfer device after the movement of the second adapter part along the first adapter part in the direction of the sealing plug and the engagement of the second adapter part.

[0027] In particular, the present invention is characterized by the fact that first and second adapter components surround a bottle to create a sealed cover, thereby providing aerosol airtightness and leak safety. For this purpose, the first adapter component is formed in a cup shape and accommodates the bottle body. The second adapter component, from which a transition element emerges, has a similar hood-like or cup-like shape that can engage with the first adapter component. Additionally, a sealing material can emerge from the second adapter component to seal the first and second adapter components to the bottle.

[0028] Based on the present invention, a transfer device is provided that, after use, i.e., after being pierced with a sealing stopper, can no longer be released from a bottle, mainly called a vial. In this case, it can be assumed that unwanted contact of the tip of the transfer element is eliminated before use of the transfer device, and as a result the risk of injury is avoided.

[0029] It is shown that the transfer element can be, for example, a needle, cannula, spike, or other puncture device. In that sense, the present invention is not limited. More precisely, the concept of a transfer element should be understood as any appropriate element that enables the transfer of a medium. Thus, different concepts, particularly puncture needles or cannulas, can also be used without thereby limiting the teachings of the present invention.

[0030] In particular, the present invention is characterized by the first adapter component comprising a sheath portion, also called a sheath wall, which surrounds the bottle from the periphery and has a hollow cylindrical shape with a front periphery extending toward the stopper side of the bottle; a bottom portion that at least partially, preferably completely, covers the bottom of the bottle; and a support portion extending toward the front periphery side, wherein a fixing element which can be formed in the shape of a tongue or a web extends from the support portion, and the fixing element which can be rotated radially of the first adapter component, or bendable or spread out and extends in the direction of the longitudinal axis of the first adapter component.

[0031] Therefore, after the vial is placed inside the first adapter component, the fixing element can support the vial in the transitional area between the vial neck and the vial body, and as a result, the first adapter component can no longer be detached from the vial.

[0032] Preferably, the support portion is an annular portion extending to the front peripheral region of the sheath portion, and is intended to be fixed, for example, to the periphery of the sheath wall in a way that allows it to be clamped or bonded, and to have a first projection that is axially deformable and extends at least partially along the inside of the sheath portion and over the front peripheral. The latter opens up the possibility that the first and second adapter components can be interlocked with each other. Based on the alternative, in the interlocked adapter component, a second projection that is engageable or interlockable in a guide such as a connecting link slit of the second adapter component extends from the outside of the sheath wall. In that case, the second projection cannot be removed from the guide during the normal operation of the transfer device.

[0033] In developing the present invention, it is proposed that the second adapter component comprises an external hollow cylindrical portion and a boundary wall extending laterally with respect to its longitudinal axis, wherein a puncture needle, i.e., a transition element, emerges from the boundary wall, or the boundary wall is penetrated by the puncture needle.

[0034] Each guide for each projection comprises a first portion extending longitudinally from the free front periphery of the outer cylindrical portion, the first portion transitioning to a second portion extending laterally toward the boundary wall, the second portion being capable of interlocking and fixing a second projection guided within it, the second projection being radially separated from the outer casing wall of the support portion of the first adapter component.

[0035] In particular, the second part of the guide is intended to have an axially tapered section, the axial magnitude of which is smaller than the axial magnitude between the maximum distances between the first and second protrusions. Before and after the axially tapered section, the axial magnitude between the boundary wall and the opposite end edge of the second part of the guide must be at least the same as the maximum distance between the separated parts of the first and second protrusions in the axial direction. Thus, the second adapter part is first guided into the first part of the guide in the axial direction, i.e., in the longitudinal direction of the vial, i.e., repositioned toward the first adapter part, in order to then rotate to bring the second protrusion to the end portion of the second part of the guide, which is limited by the tapered section, and fix it there, resulting in irreversibility between the first and second adapter parts.

[0036] In that case, the boundary of the second portion of the guide, which extends at least on the opposite side of the boundary wall, i.e., on the bottle side and forms the inner edge, extends at least partially inclined with respect to the longitudinal axis of the first adapter component, and thus the transfer device, in the direction of the boundary wall, and forms an obtuse angle with respect to the longitudinal axis.

[0037] To enable the first adapter component to guide the second adapter component without tilting, the proposed invention assumes that the inner cross-section of the hollow cylindrical portion of the second adapter component matches the outer cross-section of the sheath portion of the first adapter component.

[0038] Reliable guidance is ensured by the overlap of the adapter components, or by guides such as the axially extending connecting link slits described earlier, or by longitudinal ribs extending from, for example, one of the adapter components or from a sealing element connected thereto, particularly from the second adapter component.

[0039] In the development of the present invention, an internal hollow cylindrical portion is intended to extend coaxially with respect to the external hollow cylindrical portion of the second adapter component, in which case a protective element, preferably called a first protective element, is particularly movably positioned, and in the absence of a connection between the first adapter component and the second adapter component, the tip of the puncture needle extends between the protective element and the boundary wall of the external hollow cylindrical portion. This measure ensures that injury by the puncture needle is prevented in the second adapter component that is not connected to the first adapter component.

[0040] To enable secure fastening, that is, to ensure irreparability between adapter components, the present invention further envisions the second projection having a rectangular or trapezoidal shape in the outer projection of the sheath portion, having a corner that interacts with a step that causes a reduction in the cross-sectional area of ​​the second portion of the guide in the first and second adapter components, which are fixed together to prevent release.

[0041] Another embodiment of a transfer device according to the present invention, which cannot be released after the seal of a vial bottle has been inserted, wherein the first adapter component of the transfer device comprises a first external hollow cylindrical portion extending toward the bottle and a first internal hollow cylindrical portion with a smaller cross-section extending therefrom, the first external hollow cylindrical portion comprising a tongue-shaped portion that extends axially and constitutes a fixing element, each having a projection that radially protrudes inward in a free end region for gripping a portion of the bottle, particularly its bulging periphery, and the second adapter component is the first external hollow cylindrical portion of the first adapter component The design includes a second external hollow cylindrical portion that is movable along the outside, in which the radial position of the outward-facing tongue-shaped portion of the first external hollow cylindrical portion of the first adapter component, surrounded by the second external hollow cylindrical portion, is prevented or essentially prevented from moving, and a third external hollow cylindrical portion with a small cross-section extends from the second external hollow cylindrical portion of the second adapter component, with the second internal hollow cylindrical portion being movable inside the third external hollow cylindrical portion as the second part of the second adapter component, and a puncture needle extending from the second part.

[0042] Based on the present invention, a transfer device is introduced comprising a first adapter component capable of fixing a bottle or its neck, and a second adapter component consisting of two parts that face each other axially and are movable relative to the first adapter component. In this case, the external components of the second adapter component, in particular, when the large cross-section hollow cylindrical portion covers the first external hollow cylindrical portion of the first adapter component over the fixed axial length, the tongue-shaped portion that engages the bulging periphery of the bottle from the back can no longer be repositioned outward, and as a result, the bottle cannot be released. At the same time, both adapter components are engaged to prevent the second adapter component from being pulled back.

[0043] In particular, the external components of the second adapter component are intended to engage with the first adapter component. Preferably, a rib-like projection extending radially inward from the second external hollow cylindrical portion of the second adapter component works in conjunction with a notch, step, or shape change of the first hollow cylindrical portion of the first adapter component to prevent axial movement of the second adapter component relative to the first adapter component in the opposite direction of penetration.

[0044] In developing the present invention, it is proposed that changes in the axial position of the second adapter component relative to the first adapter component are prevented via a removable first safety device, and changes in the axial position of the second internal component relative to the third external portion of the second adapter component are prevented via a removable second safety device.

[0045] Therefore, in the existing safety device, the first and second adapter components constitute a single unit fixed in the axial direction. If the first safety device is removed after the transfer device has been pushed into the vial, the second adapter component can be pushed in as the lower unit in the penetrating direction, thereby preventing the tongue-shaped fixing element with a radially inward projection from changing position outward, and consequently preventing release from the vial, thus achieving the desired engagement between the first and second adapter components.

[0046] However, with the first safety device removed and the second safety device remaining, the puncturing needle cannot change position relative to the external part of the second adapter component. When the transfer device is fixed to the bottle by a change in the position of the second adapter component, i.e., after the removal of the first safety device, the second safety device is removed, and as a result the second internal part is movable axially toward the bottle relative to the external part of the second adapter component, which has second and third external hollow cylindrical parts, and as a result the cannula coming out of the internal part of the second adapter component can pierce the sealing stopper.

[0047] To eliminate the risk of injury from the piercing needle tip in a transfer device not connected to a bottle, one deployment involves a protective element called the second protective element extending from the first internal part of the first adapter component, with the tip of the piercing needle expected to extend between it and the second internal part of the second adapter component in an unused transfer device.

[0048] The adapter component or its portion must be shaped such that, during axial movement of the second adapter component relative to the first adapter component, the third external portion of the second adapter component is guided outward and the second internal portion is guided inward along the first internal portion of the first adapter component.

[0049] In particular, the first safety device must have an annular shape that penetrates a slit extending into the third external portion of the second adapter component and engages with a groove-like notch in the outer wall of the first internal portion of the first adapter component, which is correctly aligned therewith, when the transfer device is not in use.

[0050] Preferably, the second internal portion of the second adapter component is provided with a bottom wall on the needle tip side through which the needle penetrates, and on the side opposite to the needle tip, a flange portion is provided which extends radially outward from its surrounding wall, and particularly from the external front region of the second internal portion of the second adapter component, and the effective radial extension of the flange portion is intended to be at least the same as, and preferably larger than, the outer cross-section of the third external portion of the second adapter component.

[0051] This flange portion is used as a handle because it allows the second adapter component to be repositioned axially relative to the first adapter component, or relative to the internal part of the second adapter component, or to its external part.

[0052] Furthermore, the second safety device may similarly have the shape of a second annular portion, and in order to prevent axial movement between the first and second adapter components, the free front periphery of the third external portion and the flange portion of the second internal portion of the second adapter component are fixed together.

[0053] In deployment, the first and / or second protective elements used to protect the tip of the puncture needle from unwanted contact in the unused transfer device are disc elements, in which case the first protective element, and preferably both the first and second protective elements, are intended to be positioned on the first or second adapter component so as to be axially movable.

[0054] Furthermore, when the first and second adapter components are assembled by undercuts or snap connections, even if they have not yet been secured to the bottle, it is ensured that they cannot be disengaged from each other during proper use. These measures form a closed system. Injuries from the puncture needle are eliminated.

[0055] In one development of the present invention, in the first external hollow cylindrical portion of the first adapter component, which is engaged with the second external hollow cylindrical portion of the second adapter component at the usage position of the transfer device, the intermediate wall extending between the second and third external hollow cylindrical portions of the second adapter component is intended to abut against the intermediate wall extending between the first external hollow cylindrical portion and the first internal hollow cylindrical portion of the first adapter component.

[0056] The second safety device element remains between the third external portion and the second internal portion of the second adapter portion so that the second adapter portion can be moved axially to engage with the first adapter portion after the first adapter portion has surrounded the bottle to the required extent, that is, particularly the bulging periphery extending from the neck of the bottle.

[0057] In the development of the present invention, in the second safety device element located between the third external portion and the second internal portion of the second adapter component, the third external portion and the second internal portion are intended to be engaged in such a manner that axial positional changes in the opposite direction to the penetration direction of the piercing needle are prevented.

[0058] Regardless of that, the present invention is uniquely characterized by the fact that, in the direction of penetration of the puncture needle, the second adapter component interacts with the first adapter component in such a way that the positional change of the second component relative to the first adapter component in the opposite direction of penetration is prevented.

[0059] It is also unique to this invention that the first and second adapter components are formed to constitute a sealed container by surrounding the bottle, thereby preventing the aerosol from scattering or the leakage of the medium present in the bottle to the outside after penetration of the seal, and as a result, contamination by means of inhalation, skin, or possibly mouth is prevented. In this case, also unique to this invention, the second element having a transition element may be equipped with a sealing material, which seals the second adapter component to the bottle, and in particular to both the bottle and the first adapter component.

[0060] In other words, the present invention is also characterized by a transfer device for taking a medium out of or into a bottle having a neck of bottle that can be sealed via a stopper, comprising a first adapter component that is positionable on the bottle and a second adapter component that has a transition element for penetrating the stopper and interacts with the first adapter component to move longitudinally along the bottle, wherein the first and second adapter components are movable relative to each other, so as to surround the bottle to form a sealed container. In this case, preferably the second adapter component is provided with a sealing material so as to be sealed by the second adapter component to the bottle and / or the first adapter component. Preferably, both adapter components are given the same non-releasability.

[0061] In the development of the present invention, the non-releasability of both adapter components is intended to be achieved through the engagement of a projection into a notch, which must be moved relative to each other only in the direction of penetration of a transition element such as a cannula, and which can no longer be separated in the reverse direction.

[0062] Engagement can be achieved by a tongue-shaped element equipped with a fixed hook that interacts with the corresponding element. The tongue-shaped elements may have different lengths.

[0063] The present invention also includes a sealing element for preventing the leakage of liquids, dust, aerosols, etc., from a sealed space. In this case, the sealing element can seal both adapter parts facing each other or from above and below. Possible forms of the sealing element may include notches, recesses, projections, or similar features that surround and annular in order to close the space to the environment. The sealing element can be placed between the external parts of the adapter, between the internal parts, or between the internal and external parts of the adapter. The sealing element may optionally seal directly to the bottle.

[0064] Similarly, the sealing element can be finished to form further guide grooves so that the adapter parts can be easily moved toward each other or the bottles within the adapter parts.

[0065] Other forms are revealed by the claims.

[0066] The teachings based on the present invention highlight the advantage of providing aerosol airtightness, particularly in vials, when the vial is punctured.

[0067] Furthermore, this invention also makes it possible to avoid dangerous leaks after the sealing plug has been penetrated.

[0068] Aerosols generated in or around the vial during the separation process can be prevented by leaving the adapter in place. Furthermore, aerosol airtightness during use is also provided.

[0069] Another advantage of the present invention that should be emphasized is the elimination of injuries caused by transfer elements such as needles, cannulas, spikes, and puncture devices after use of the transfer device.

[0070] A kit comprising a container holding a medical drug, a bag containing a solvent for dissolving the medical drug, and a transfer device for mixing the medical drug with the solvent is also subject to the present invention.

[0071] Further details, advantages, and features of the present invention are revealed not only by each claim which refers to features individually and / or in combination, but also by the following description of the drawings which refer to preferred embodiments. [Brief explanation of the drawing]

[0072] [Figure 1] An exploded view of the first embodiment of the transfer device is shown. [Figure 2] Figure 1 shows the first adapter component of the transfer device. [Figure 3] Figure 1 shows the second adapter component of the transfer device. [Figure 4a] The transfer device shown in Figure 1 is depicted in the plan view. [Figure 4b]The transfer device shown in Figure 1 is shown in a cross-section along line segment CC. [Figure 5a] The transfer device shown in Figure 1 is depicted in the plan view. [Figure 5b] The transfer device shown in Figure 1 is shown in a cross-section along line segment DD. [Figure 6a] The transfer device shown in Figure 1 is depicted in the plan view. [Figure 6b] The transfer device shown in Figure 1 is shown in a cross-section along line segment EE. [Figure 7a] The transfer device shown in Figure 1 is depicted in the plan view. [Figure 7b] The transfer device shown in Figure 1 is shown in a cross-section along the line segment FF. [Figure 8] A side view of a second embodiment of the transfer device is shown. [Figure 9] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 10] The transfer device described in Figures 8 and 9 is shown in a cross-section along line segment AA. [Figure 11a] Figure 8 shows the transfer device with a vial bottle incorporated in the plan view. [Figure 11b] Figure 8 shows the transfer device having a vial bottle incorporated in a cross-section along line segment BB. [Figure 12a] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 12b] The transfer device shown in Figure 8 is located in a cross-section along line segment CC. [Figure 13a] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 13b] The transfer device shown in Figure 8 is located in a cross-section along line segment DD. [Figure 14a] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 14b] The transfer device shown in Figure 8 is located in a cross-section along line segment EE. [Figure 15a] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 15b]The transfer device shown in Figure 8 is located in a cross-section along the line segment FF. [Figure 16a] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 16b] The transfer device shown in Figure 8 is located in a cross-section along the line segment GG. [Figure 17a] The transfer device shown in Figure 8 is depicted in the plan view. [Figure 17b] The transfer device shown in Figure 8 is located in a cross-section along line segment HH. [Figure 18] Alternative means for the transfer device embodiments described in Figures 1 to 7b are shown in cross-sectional views. [Figure 19] Figure 18 shows a side view of the transfer device described. [Figure 20] Figure 18 shows a cross-section along line segment AA. [Figure 20a] The cross-sectional view shows the deformation of the transfer device described in Figure 18. [Figure 20b] The cross-sectional view shows the details of the deformation of the transfer device described in Figure 18. [Figure 21] Figure 20 shows the details. [Figure 22] Figures 18 to 21 show exploded views of the transfer device. [Figure 23a] The transfer device shown in Figure 22 is depicted in the plan view. [Figure 23b] The transfer device shown in Figure 22 is shown in a cross-section along line segment BB. [Figure 24a] The transfer device shown in Figure 22 is depicted in the plan view. [Figure 24b] The transfer device described in Figure 22 is shown in a cross-section along line segment CC. [Figure 25a] The transfer device shown in Figure 22 is depicted in the plan view. [Figure 25b] The transfer device described in Figure 22 is shown in a cross-section along line segment DD. [Figure 26a] The transfer device shown in Figure 22 is depicted in the plan view. [Figure 26b] The transfer device shown in Figure 22 is shown in a cross-section along line segment EE. [Figure 27a] The transfer device shown in Figure 22 is depicted in the plan view. [Figure 27b] The transfer device shown in Figure 22 is located in a cross-section along the line segment FF. [Figure 28a] The transfer device shown in Figure 22 is depicted in the plan view. [Figure 28b] The transfer device shown in Figure 22 is located in a cross-section along the line segment GG. [Figure 29] Another embodiment of the transfer device, as an alternative to Figures 18 to 28b, is shown in a plan view. [Figure 30] Figure 29 shows a side view of the transfer device described. [Figure 31] Figure 29 shows a cross-section along line segment AA. [Figure 32] Figure 31 shows details. [Figure 33a] The transfer device shown in Figures 29 to 32 is depicted in the plan view. [Figure 33b] The transfer apparatus shown in Figures 29 to 32 is depicted in a cross-section along line segment CC. [Figure 34a] The transfer device shown in Figures 29 to 32 is depicted in the plan view. [Figure 34b] The transfer apparatus shown in Figures 29 to 32 is depicted in a cross-section along line segment DD. [Figure 35a] The transfer device shown in Figures 29 to 32 is depicted in the plan view. [Figure 35b] The transfer apparatus shown in Figures 29 to 32 is depicted in a cross-section along line segment EE. [Figure 36a] The transfer device shown in Figures 29 to 32 is depicted in the plan view. [Figure 36b] The transfer apparatus shown in Figures 29 to 32 is depicted in a cross-section along the line segment FF. [Figure 37a] The transfer device shown in Figures 29 to 32 is depicted in the plan view. [Figure 37b] The transfer apparatus shown in Figures 29 to 32 is depicted in a cross-section along the line segment GG. [Figure 38a]The transfer device shown in Figures 29 to 32 is depicted in the plan view. [Figure 38b] The transfer apparatus shown in Figures 29 to 32 is depicted in a cross-section along line segment HH. [Figure 39] The exploded view shows the transfer device described in Figures 29 to 32. [Modes for carrying out the invention]

[0073] In diagrams where essentially identical elements are given the same reference numerals, transfer devices are shown for transferring fluids, such as dry substances mixed before use or administration, or liquids, such as water or solvents, from a vial or bottle, so-called vial, for infusion or injection purposes. Similarly, they can be used for drip infusion or solvent bags. Other use cases are given purely as examples. The corresponding transfer devices are also called connectors or adapters. A corresponding transfer device is needed to connect a vial to another container or infusion device, such as a syringe, infusion bag, solvent bag, or syringe, after puncturing the stopper of the vial using a transfer element such as a steel cannula or other puncture needle, and then supplying the fluid extracted from the vial via the transfer device to another container or infusion device.

[0074] The transfer device shown in the figure comprises components, also called first and second adapter parts, arranged in a telescope-like configuration and adjustable relative to each other. For simplicity, the transfer device will be referred to as a connector below, and the small bottle connected to it will be referred to as a vial. The first adapter part will also be called a vial holder, and the second adapter part will also be called a cannula holder.

[0075] Furthermore, the transition element that creates a connection to the inside of the vial without imposing any limitations on its function or form is called a cannula.

[0076] It should be understood that these are purely examples regarding the given shapes of the parts, and it should be noted that they may differ as long as the fundamental principles of the invention can be realized. Furthermore, the figures are self-explanatory. In this, the features forming the present invention can be clearly recognized. [Examples]

[0077] The connector 10 shown in Figures 1-7 comprises a first adapter component 12 and a second adapter component 14 as basic elements. The first adapter component 12 has a cup shape with a circumferential wall 16 called a sheath wall and a bottom wall 18 to accommodate a small bottle, i.e., a vial bottle 20, that can be inserted into the first adapter component 12. The bottom wall 18 ensures that the vial bottle 20 remains inside the first adapter component 12. For this purpose, the bottom wall 18 does not need to be completely closed. However, a closed bottom wall 18 is preferably planned to provide a closed system that offers the possibility of aerosol airtightness and leak airtightness as described below.

[0078] As can be seen from the detailed view in Figure 2, a support element called an annular element or annular portion 22 is provided in the open peripheral region of the surrounding wall 16, also called the casing portion, and some of the support elements have an axially compressible elastic first projection on the front peripheral side, some of which are characterized by reference numerals 24 and 26. As is clear from the detailed view based on Figure 2, the annular element 22 partially grips the front peripheral edge of the circumferential wall 16 to ensure fixation.

[0079] From the region of the annular element 22 extending inside the sheath wall 16, some elements, also called fixing elements, extend axially in a web-like or tongue-like manner and are characterized by reference numerals 28 and 30. In particular, as is clear from the exploded view based on Figure 1 and Figures 4-7, the tongue-like elements 28 and 30 extend inclined with respect to the longitudinal axis 32 of the first adapter part 12 and consequently the vial bottle 20, thereby securing the first adapter part 12 to the vial bottle 20. Next, as shown in Figures 4-7, the tongue-like elements 28 and 30 are supported on a connecting wall 38, also called a transient, which extends diagonally between the neck 34 of the vial bottle 20 and its cylindrical body 36, in the vial bottle 20 positioned within the first adapter part 12. As a result, the vial bottle 20 can no longer be withdrawn from the first adapter part 12. Thus, the first adapter part 12 is a vial bottle holder.

[0080] It should be noted that the neck 34 of the vial 20 has a bulge 40 surrounding its opening. The opening of the vial 20 is sealed by a stopper 42. Furthermore, it should be noted that, typically, after the vial 20 is sealed with a stopper 42, an aluminum flange cap is fitted. There may be a plastic flip-off cap on top of that. This flip-off cap is removed from the aluminum flange cap, resulting in an opening in the center of the aluminum flange cap, which in turn allows the stopper 42 to be seen.

[0081] The second adapter component 14, also called the adapter component or external component, includes a hollow cylindrical portion 44 defined by a wall 46, also called a boundary wall, which extends laterally with respect to the longitudinal axis 32 on the opposite side of the vial, the wall 46 having a cylindrical projection 48 in the center, from which a puncture needle 50 called a cannula emerges on one side, and a snap-off connector 52 is fitted over the outside of the cylindrical projection on the other side. Thus, the second adapter component 14 is a cannula holder.

[0082] Recesses 56 and 58 that constitute guides are formed in the inner wall 54 of the hollow cylindrical portion 44 of the second adapter component 14 (Figure 3), and each recess is composed of a portion 60 that extends axially and a portion 62 that extends laterally and along the wall 46. Each guide 56 and 58 is assigned to a second projection 64 or 66 that protrudes radially outward from the circumferential wall 16 of the first adapter component 12 so that the first adapter component 12 can be interlocked with the second adapter component 14 in the method described below (Figure 2).

[0083] As is particularly clear from Figures 4-7, an internal hollow cylindrical portion 68 extends coaxially with the external hollow cylindrical portion 44, and the cannula 50 extends inside it, but does not protrude beyond its front peripheral edge 70. In the drawings corresponding to the embodiment, a disc-shaped protective element 72 is clamped and housed by the internal hollow cylindrical portion 68, and the protective element is adjustable in the axial direction of the internal hollow cylindrical portion 68. However, in the unused connector 10, the tip 74 of the cannula 50 extends between the protective element 72 and the wall 46, and is therefore covered on the outside, thus protecting the user from injury. One non-compulsory form of the protective element 72 is shown.

[0084] For example, instead of the disc-shaped protective element 72, a thin film may extend from the front peripheral edge 70 of the internal hollow cylindrical portion 68, and this thin film may be broken during the assembly of both adapter parts 12 and 14, or during the axial movement of the vial 20 and the second adapter part 14 toward the first adapter part 12.

[0085] As shown in the drawings based on Figures 2 and 3, the internal portions 62 of the guides 56 and 58, which extend laterally with respect to the longitudinal axis 32, are provided with an axial section reduction formed by a step 76. This step 76 gives portion 62 a so-called "narrow section," that is, the distance between the free edge or corner 78 of each second projection 64 and 66 and the vertex region of the first projections 24 and 26 becomes greater than the distance between the vertex of the step 76 and the opposite periphery of portion 62. In other words, the first projections 24 and 26 must be compressed in order to overcome the step 76. After the protrusions 64 and 66 enter the interior of the end portion 80 of the portion 62 that extends along the wall 46 of the guides 56 and 58, the protrusions 24 and 26 can expand again, and as a result, if the first adapter part 12 rotates relative to the second adapter part 14 in the direction of the step 76, the protrusions 64 and 66 that protrude from the outside of the sheath wall 16 are prevented from rotating further by their interaction with the step 76. Thus, the first and second adapter parts 12 and 14 are irrevocably connected to each other. The vial 20 is also irremovable.

[0086] To assist in axial guidance between adapter parts 12 and 14 during joint pressing, longitudinally extending ribs 17 and 19 can be utilized on the outer wall 16 to act as guide rails.

[0087] The connection of the cannula 50 into the vial 20 is clearly shown in Figures 4-7. In Figure 4, the fixed position in which the second adapter part 14 is attached to the first adapter part 12 is shown. In this case, the second adapter part 14 surrounds and is guided by the outer wall 16 using the outer hollow cylindrical part 44. The inner diameter of the hollow cylindrical part 44 and the outer diameter of the outer wall 16 are adjusted to correspond to each other to prevent tilting. The guide ensures that the cannula can move along the longitudinal axis 32 of the vial 20 when the first and second adapter parts 12 and 14 are pushed and moved toward each other. However, especially when both adapter parts 12 and 14 are moved toward each other, ribs 17 and 19 extending in the longitudinal direction are used to adjust them toward the correct fixed position. Also, linear contact is created between both adapter parts 12 and 14, making movement easier. Tilting is also prevented by the ribs 17 and 19.

[0088] Figure 5 shows the fixed position in which the cannula 50 penetrates the stopper 42 and the cannula tip 74 is connected to the inside of the vial 20. In this position, the projections 64, 66 that protrude from the outside of the sheath wall 16 and preferably have an irregular trapezoidal shape are in the transition between the axially extending portion 60 and the laterally extending portion 62 of the guides 56, 58. Next, the upper adapter component, i.e., the second adapter component 14, is rotated relative to the lower, i.e., the first adapter component 12 (Figure 6), so that the second projections 64, 66 are repositioned along the portion 62 of the guides 56, 58 that extends along the wall 46. The first and second adapter components 12, 14 interlock when the second projections 64, 66 have crossed the step 76 in the portion 62 of the guides 56, 58 and are within the respective terminal portions 80 of the guides 56, 58. In order to overcome step 76, it is necessary that the first protrusions 24 and 26, which protrude axially from the front peripheral edge of the annular element 22, be compressed by the required amount beforehand.

[0089] In that case, the interlock is designed to be released only by using an additional tool or by using a pull-out force of at least, for example, 300 N.

[0090] After connection to the vial 20, the break-off connector 52 is broken, and mixing is ensured between the drug present in the vial 20 and the liquid in the bag pre-connected to the break-off connector 52. Basically, Luer lock connections are also possible. Similar devices such as break-off connectors or Luer lock connections can also be used for syringes, bottles, or similar containers. The same applies to all embodiments. [Examples]

[0091] Figures 8 to 17 show a second embodiment of the connector 100, which is composed of a first adapter component 112, a vial holder extending to the vial side, and a second adapter component 114, a cannula holder equipped with a cannula 50. In this case, the connector 100 is similarly formed so that, after connection to the vial 20, unintentional or uncontrolled disconnection from the vial 20 is no longer possible, as will be described below.

[0092] The first or internal adapter component 112 includes a first external hollow cylindrical portion 116 that surrounds the bulge 40 of the vial 20 when in proper use, and an internal hollow cylindrical portion 118 having a smaller diameter than the external hollow cylindrical portion 116. Between the two hollow cylindrical portions 116, 118, an intermediate wall 120 extends laterally, particularly vertically, with respect to the longitudinal axis 32 of the connector 100 and, consequently, with respect to the longitudinal axis of the vial 20 when connected to the vial 20.

[0093] The outer hollow cylindrical portion 116 is divided by an axially extending slit 122 and biased to the required extent, and comprises tongue-shaped portions characterized by, for example, two reference numerals 124 and 126. Both tongue-shaped portions 124 and 126 have inwardly projecting protrusions (see projection 128) at their ends, which rear-engage with the bulging periphery 40 of the vial neck when the first adapter component 112 is properly connected to the vial 20, as can be seen below from the figures.

[0094] The second or external adapter component 114 is composed of two components that are telescopically adjustable relative to each other, more specifically, an external component 130 and an internal component 132 from which the puncture needle 50 emerges. The external component 130 includes a portion 134 called the second external hollow cylindrical portion and a portion 136 called the third external hollow cylindrical portion, which have different diameters from each other. In this case, the third external hollow cylindrical portion 136 is smaller in cross-section than the second external hollow cylindrical portion 134, and the inner diameter of the second external hollow cylindrical portion is matched to the outer diameter of the first external hollow cylindrical portion 116 of the first adapter component 112, thereby enabling axial guidance. Furthermore, the inner diameter of the third external hollow cylindrical portion 136 is matched to the outer diameter of the first internal hollow cylindrical portion 118 of the first adapter component 112, thereby similarly providing axial guidance.

[0095] To attach the connector 100 to the vial 20, the first and second adapter parts 112, 114 are protected from axial positional changes by a first safety device 138, which preferably has the shape of an annular portion. The safety device 138 extends along another intermediate wall 140 that extends between the second and third hollow cylindrical portions 134, 136 and parallel to the intermediate wall 120, and passes through a slit in the third outer hollow cylindrical portion 136, and partially extends into a notch or groove in the first inner hollow cylindrical portion 118 of the first adapter part 112, which is properly aligned with the slit. Furthermore, a second safety device 146 extends between the front periphery 142 of the third outer hollow cylindrical portion 136 of the second adapter part 112 and the internal, i.e., flange-like extension that exits from the second part 132.

[0096] The internal component 132 of the second adapter component 114 has a hollow cylindrical shape whose outer diameter matches the inner diameter of the first internal hollow cylindrical portion 118 of the first adapter component 112, thereby enabling axial guidance. Furthermore, the second component 132 of the second adapter component 114 is secured to the first internal hollow cylindrical portion 118 via a meshing portion, particularly preferably a surrounding rib 133, which protrudes from the hollow cylindrical interior of the second adapter component 114, i.e., the circumferential wall of the second component 132, and engages with a correspondingly fitting notch 153 located inside the first internal hollow cylindrical portion 118 of the first adapter component 112.

[0097] Furthermore, the drawings show that a projection such as a clamp rib 147 protrudes from the second external hollow cylindrical portion 134 of the second adapter part 114, and this clamp rib engages with a matching notch 148 of the first external hollow cylindrical portion 116 of the first adapter part 112, so as to prevent the two adapter parts 112 and 114 from being released in the opposite direction of penetration. Thus, before the connector 100 is attached to the vial 20, there is a single unit consisting of the first and second adapter parts 112 and 114.

[0098] To eliminate the possibility of the user coming into contact with the tip 74 of the cannula 50, a disc-shaped protective element 172 based on a non-compulsory alternative form corresponding to the embodiments in Figures 1-7 can be clamped and housed in the first internal hollow cylindrical portion 118 of the first adapter component 112, and the protective element may have a central opening so as not to obstruct the penetration of the cannula 50 when piercing the plug 42. A thin film that is broken can also be planned instead of the disc element.

[0099] Based on Figures 11-17, it can be seen how the connector 100 is connected to the vial 20 and penetrates its stopper 42. The figures are self-explanatory in that sense.

[0100] In Figure 11, the connector 100 is positioned so that it fits correctly onto the neck 34 of the vial 20, with the longitudinal axis of the connector 100 matching the longitudinal axis 32 of the vial 20. The second adapter part 114 is positioned relative to the first adapter part 112 based on safety devices 138, 146 and interlocking projections or clamping ribs, so that the first adapter part 112 can overcome the bulge 40 of the vial neck 34, that is, so that the tongue-shaped portions 124, 126 can be spread outward so that the biasing force is immediately returned once the bulge 40 has been overcome, and so that the projections 128 of the tongue portions 124, 126 can engage the bulge 40 from the back. The position of the connector 100 after the bulge 40 is engaged from the back is shown in Figure 13.

[0101] Next, the first safety device 138, which extends along the intermediate wall 140 and protects the first and second adapter parts 112 and 114 against axial position changes, is removed (Figure 14), and as a result, Further axial force causes axial movement of the second adapter component 114. Prior to this, the support force generated by the clamp rib, also called a projection 133 or rib, which connects the second component 132 to the first internal hollow cylindrical portion 118 of the first adapter component 112, is overcome.

[0102] Figure 15 shows the fixed position in which the second external hollow cylindrical portion 134 surrounds the first external hollow cylindrical portion 116 of the first adapter component 112 to such an extent that it is no longer possible to bend the tongue-shaped elements 124 and 126, also called tongue-shaped portions, outward. At the same time, the projection 147, which prevents the second adapter component 114 from being pulled back relative to the first adapter component 112, engages with the notch portion adjusted by the stepped notch 148 in the free peripheral region of the tongue-shaped elements 124 and 126 from the back, thereby ensuring that the second adapter component 114 cannot be pulled back, i.e., its position cannot be changed in the axial direction opposite to the penetration direction.

[0103] Therefore, the second external hollow cylindrical portion 134 acts as a clamping ring at its end for the first external hollow cylindrical portion 116, also called the bell-shaped portion of the first adapter component 112, thereby preventing radial positional changes of the tongue-shaped elements 124 and 126 facing outward. This creates a sealed space before the stopper is inserted, and as a result, the aerosol generated by the opening of the vial does not leak out.

[0104] In this case, the interlock provided is manufactured so that it can only be released by an additional tool or, for example, a tensile force of 300 N. This ensures that the connector 100 remains connected to the vial 20 after use.

[0105] Next, the second safety device 146 is removed, and as a result, the internal component 132 of the second adapter component 114, which is equipped with the cannula 50, can be repositioned in the penetrating direction by the action of an axial force on the flange-shaped handle 144 in order to penetrate the plug 42, as is evident from the comparison in Figures 15-17. During the final axial reposition of the internal component 132 of the second adapter component 114, the disc-shaped protective element 172 is pressed against the outside of the plug 42, or against the aluminum cap covering the outside, by the lateral wall 150 of the internal component 132 which extends inward and is penetrated by the cannula 50. Furthermore, to prevent the internal component 132 of the second adapter component 114 from being pulled back, the projection or clamp rib 133 that protrudes radially from the outer wall of the hollow cylindrical portion of the internal component 132 of the second adapter component 114 engages with a notch in the inner wall of the first internal hollow cylindrical portion 118 of the first adapter component 112, or engages with a step 152 from the back.

[0106] After the second adapter component 114 is properly secured, the break-off connector 52, which is pre-attached to the bag, is then broken in order to perform the desired mixing procedure. [Examples]

[0107] Figures 18-28 show alternative means for the embodiments shown in Figures 1-7, but essentially the same elements are given the same reference numerals. In that case, the representation of the corresponding transport device 200, also called a connector, is immediately obvious.

[0108] In the transfer device or connector 200, the non-removability of the adapter component is achieved by the engagement of the second adapter component 214 with the outside by the first adapter component 212 surrounding the vial bottle 20. In this case, the assembled adapter components 212 and 214 have the advantage of surrounding a sealed space in which the stopper 42 of the vial bottle 20, through which it is inserted, is located.

[0109] The first adapter component 212 has a cup shape with a circumferential wall 216 and a bottom wall 218 for accommodating the vial bottle 20. Similarly, an annular element 222 is provided in the open peripheral region of the circumferential wall 216, and from this annular element, web-like or tongue-like elements extend axially, characterized, for example, by reference numerals 228 and 230. As is particularly evident in Figures 20, 21 and 22, the tongue-like elements 228 and 230 are inclined with respect to the longitudinal axis 232 of the connector 200 and thus the vial bottle 20, so that the first adapter component 212 and the vial bottle 20 constitute a single fixed unit when the vial bottle 20 is properly accommodated by the first adapter component 212, in which case, in the vial bottle 20 positioned within the first adapter component 212, the tongue-like elements 228 and 230 support a connecting wall 38 extending between the vial neck 34 and its cylindrical body 36 of the vial bottle 20. Therefore, the vial 20 can no longer be withdrawn from the first adapter part 212.

[0110] From an annular element 222 connected by adhesive or welding to the front periphery of the cup-shaped first adapter component 212, another tongue-shaped element 223, 231 extends further inward, and this additional tongue-shaped element makes close contact with the circumferential surface of the vial 20, i.e., the cylindrical body 36, corresponding to the representation based on Figure 25, for example. The second tongue-shaped elements 223, 231, which are longer than the first tongue-shaped elements 228, 230 that are used as safety devices, are used as positioning aids for the first adapter component 212, and thus concentrically surround the vial 20.

[0111] As is evident from the cross-sectional view based on Figure 20, the first adapter part 212 has engagement recesses on its circumferential side that are defined by ridges. For example, two engagement recesses are characterized by reference numerals 310 and 312. The projections defining the engagement recesses 310 and 312 have a tooth-like shape so that the insertion side of the second adapter part 214, i.e., the upper boundary in the depicted figure, extends in a sloping manner, allowing the projections 322 and 324 of the tongue-shaped and axially extending elements 314, 316, 318, and 320 of the second adapter part 214 to slide along the corresponding side. The opposite side has an appropriately inclined extension direction, and as a result, when the projections 322, 324 extending from the tongue-shaped elements 314, 316 engage within the engagement recesses 310, 312, it is no longer possible to separate the adapter parts 312, 314 with the application of normal force.

[0112] Axial-extending tongue-shaped elements 314, 316, 318, and 320, having inwardly facing projections 322 and 324 at their ends, extend from an annular element 326, which is fixed by welding in the opening region of the second adapter component 214. In this region, the second adapter component 214 has a bell-shaped form, as is particularly evident from its cross-sectional view in Figure 20. Correspondingly, the annular element 326 has a bulging periphery 328 which is connected by welding to the bell-shaped extension 330 of the second adapter component 214. The tongue-shaped elements 314, 316, 318, and 320 are formed to be tilted inward toward the second adapter component 214 and biased to allow the first and second adapter components 212 and 214 to push into each other without problems, but to prevent them from pulling apart as previously described. In this case, the interlock is manufactured so that it can be released using an additional tool or by using a tensile force of at least, for example, 300 N.

[0113] Furthermore, the inner wall of the cylindrical portion of the second adapter part 214 is lined with a sealing material 332 that seals both assembled adapter parts 212 and 214 and makes close contact with the outer wall 216 of the first adapter part 212. This creates a sealed space. If the bottom wall 218 of the first adapter part 212 is similarly sealed, the vial 20 is completely sealed to the surroundings. This is a preferred configuration.

[0114] Figure 22 also shows that the sealing material 332 may have an annular protrusion 333 extending around the circumference.

[0115] As shown in the embodiments of Figures 1-7, an internal hollow cylindrical portion 268 extends coaxially with the hollow cylindrical circumferential wall 244 of the second adapter component 214, which transitions to the boundary wall or bottom wall 245, and has a projection 270 that preferably surrounds the second adapter component with its end facing inward, and the projection engages with the bulging periphery 40 of the vial 20 from the rear in the assembled first and second adapter components 212, 214, as is evident from the depiction based on Figure 21, for example. This provides additional protection against the separation of the adapter components 212, 214 from each other.

[0116] Furthermore, a stopper, preferably formed as an annular or web 217 surrounding the outer wall 216, extends radially from the circumferential wall. When both adapter parts 212 and 214 are properly assembled and the cannula 50 is inserted into the vial 20 in the required amount, the free outer edge of the second adapter part 214 is in close contact with this stopper.

[0117] Figures 23a) to 28b) clearly show the connection of the cannula 50 to the inside of the vial 20. Specifically, Figures 23a) and 23b) show the first adapter part 212 surrounding the vial 20 being added to the second adapter part 214. Figures 24a) and 24b) depict the connection. In Figures 25a) and 25b), the projections 322 and 324 protruding from the tongue-shaped elements 314, 316, 318, and 320 at their terminal regions are depicted as already engaged in the engagement notches or engagement recesses 310, thus providing an interlock position, however the stopper 42 has not yet been fully inserted.

[0118] Figures 26a) and 26b) depict the position where the first adapter part 212 is further pushed into the second adapter part 214. A deeper engagement is visible in Figures 27a) and 27b). Figures 28a) and 28b) show the final position where the free edge of the second adapter part 214 is in close contact with the annular projection 217 of the first adapter part 212, which is used as a stopper. At the same time, a projection 270 extending from the peripheral region of the internal hollow cylindrical portion 268 of the second adapter part 214 and facing inward, preferably at least partially surrounding it, engages the bulging expansion portion 40 of the vial 20 from the rear. With both adapter parts 212 and 214 pushed in together, and the second adapter part 214 in close contact with the stopper formed by the projection 217, the stopper 42 is completely pierced by the cannula 50.

[0119] Naturally, the stopper is not a mandatory feature. More precisely, optical markings, such as colored markings, can also be used to let the user know that both adapter parts 212 and 214 have been pushed into each other to a certain extent, and that the stopper 42 has been inserted through the cannula 50 to the required extent.

[0120] Therefore, after the adapter parts 212 and 214 are properly pushed in, the snap-off connector 52 protruding from the bottom wall 245 of the second adapter part 214 can be removed.

[0121] With respect to the engaging notches or recesses 310, 312 and the engaging protrusions 322, 324, it should also be noted that, based on one alternative, the engaging notches 310, 312 are threaded portions into which the protrusions 322, 324 engage, and as a result, the connection between the two adapter parts 212, 214 is possible by assembling the first adapter part 212 with the second adapter part 214 in a screw connection manner. However, irreversibility is similarly given by the fact that in the final state, at least the protrusions 270 protruding inward from the internal cylindrical portion 268 engage the bulging periphery 40 of the vial 20 from the back. Naturally, multiple protrusions or a single surrounding protrusion can also be planned.

[0122] Figures 20a and 20b show one embodiment of the transfer device 200 shown in Figures 18-28. Since the structure is basically the same, the same reference numerals are used for the same elements. The embodiment of the transfer device shown in Figures 20a and 20b differs from that of Figures 18-28 in that there is no projection extending inward from the internal hollow cylindrical portion 268 to engage the bulging periphery 40 of the vial 20 from the back. Otherwise, the structure is identical. In particular, the figures can be identified that in the assembled adapter parts 212 and 214, the circumferential portion or sheath portion 216 of the first adapter part 212, which has an annular element 222, extends into an annular slit 269 that extends between the internal hollow cylindrical portion 268 and the circumferential wall 244. Therefore, the annular slit 269 provides a guide when pushing the two adapter parts 212 and 214 together. At the same time, sealing is achieved between the annular element 222 and the annular slit 269, and consequently between the two adapter parts 212 and 214. [Examples]

[0123] Figures 29-39 show an embodiment of an alternative to the transfer device called a connector for Figures 18-28. In this case, the same reference numerals are used for the same elements. In the transfer device 400 as well, as soon as the first and second adapter parts 412 and 414 are connected to each other by engagement, a hood shape or cup shape is given based on the irreversibility between the first adapter part 412 and the second adapter part 414 surrounding the vial bottle 20 having a seal stopper 42. Furthermore, the first and second adapter parts 412 and 414 surround a sealed space surrounding the vial bottle 20, in which case the space is already closed before the cannula 50 exiting the second adapter part 414 enters the seal stopper 42.

[0124] Basically, "impossible to release" means that it cannot be released without tools, or by a tensile force of 300N or less.

[0125] The first adapter component 412 has a cup shape with a circumferential wall 216 and a bottom wall 218 for accommodating the vial 20. Engaging recesses, defined by ridges, extend from the circumferential wall 216, also called the casing wall, and these engagement recesses are characterized, for example, by two reference numerals 310 and 312. The projections defining the engagement recesses 310, 312 have a serrated shape on the side extending toward the insertion side relative to the second adapter component 414, i.e., the upper boundary in the drawing, respectively, which extends in a sloping manner. This allows for the problem-free pushing of the second adapter component 414 onto the first adapter component 412, or the pushing of the first adapter component 412 into the second adapter component 414, as will be described below. The structure of the engagement recesses 310, 312 and the projections defining them can be clearly seen in Figure 32.

[0126] In the assembled first and second adapter parts 412, 414, radially inward projections 423, 425 of axially extending tongue-shaped elements of the second adapter part 414, some of which are characterized by reference numerals 416, 418, 420, 424, act on the engaging recesses 310, 312 to make it impossible to release, i.e., to pull them apart in the opposite direction of penetration of the cannula 50. The tongue-shaped elements 416, 418, 420, 424, which constitute the engaging hook using their radially inward projections 423, 425, extend from an annular element 430 that is bonded to the second, i.e., outer adapter part 414, particularly by welding or bonding. Other fastening methods are similarly possible.

[0127] In this case, the annular element 430 is fixed to the internal region of the second adapter component 414, preferably to the bell-shaped extension 432, as is particularly evident in Figure 31. The tongue-shaped elements 416, 418, 420, and 424 extending from the annular element 430 in the direction of the bottom wall 434 that extends laterally with respect to the longitudinal axis of the adapter component 414, are aligned with the outer circumference of the first adapter component 412 and tighten the surrounding periphery, i.e., the cover, thereby ensuring no tilting, or more precisely, a secure axial guide, when inserting the first adapter component 412 with the vial bottle 20 into the second, i.e., outer adapter component 414.

[0128] To create a seal when the first adapter part 412 is inserted into the second adapter part 414 to form a single unit, a sealant 436 extends inward from the second adapter part 414. This sealant consists of an inner portion 438 extending in the longitudinal direction of the adapter part 414 and an outer portion 446 parallel to it, forming a slit. In cross-section, the sealant 436 has an unequal-legged U-shape, with its shorter leg extending outward. Within this slit, as is clearly visible in Figure 32, the peripheral portion 440 of an internal hollow cylindrical portion 444 extending coaxially with the circumferential wall 442 of the second adapter part 414 extends. The sealant 436 is bonded to the hollow cylindrical portion 444, connected in another suitable manner, or otherwise secured by fastening. In that case, the outer surface of the outer portion 446 of the sealing material 436 extends in a straight line with respect to the outer surface of the hollow cylindrical portion 444, as can also be seen from Figure 32. When the first and second adapter parts 412 and 414 are pressed together, the outer portion 446 of the sealing material 436 slides along the inside of the circumferential wall 216 of the first adapter part 412, thereby sealing the outer adapter part 414 against the first, i.e., inner adapter part 412.

[0129] As can be seen in Figure 39, the inner surface of the inner portion 438 of the sealing material 436 is provided with longitudinal ribs 439 that are used to guide the vial bottle 20. Furthermore, as can be seen in Figure 32, the inner portion 438 tapers outward from its periphery (line 441). This similarly guides the vial bottle 20. At the same time, as can be seen in Figure 32, a seal is provided on the vial bottle 20. In addition, a projection 447 exists on the outside of the outer portion 446 of the sealing material 436, which provides a seal between the first adapter part 412 and the second adapter part 414 in the region of the engagement recesses 310 and 312. This ensures a seal between the first and second adapter parts 412 and 414. As already mentioned, the sealing material also makes close contact with the vial bottle 20 or its diagonally extending neck portion (connecting wall 38).

[0130] The combined action of the engaging projections 423, 435 of the tongue-shaped fixing elements 416, 418, 420, 424 and the engaging recesses 310, 312 ensures that, based on the firm fixation of the engaging projections 423, 425 within the recesses 310, 312, it becomes impossible to separate the two adapter parts 412, 414. Conversely, based on their shape, it is ensured that only pushing in the direction of penetration is possible before the stopper 42 is inserted. This creates a sealed space before the stopper is inserted, and as a result, aerosols generated through the opening of the vial do not reach the outside.

[0131] Penetration is achieved by further pushing of the two adapter components 412 and 414 together, to the extent that the cannula 50 penetrates the plug 42 and, in that case, the cannula 50 completely pierces the plug 42. In this case, the pushing of the two adapter components 412 and 414 together is possible to the extent that the lower edge of the second adapter component 414, or the annular element 430 extending into this region, protrudes from the circumferential wall 216 of the first adapter component 412 and closely surrounds the web 217 in the radial direction, as was the case in relation to the embodiments in Figures 18-28.

[0132] The combined action of the first and second adapter components 412 and 414 until the cannula 50 completely penetrates the sealing plug 42 is clearly evident from Figures 33-38.

[0133] In other words, Figure 33 shows that after the vial 20 is inserted into the lower adapter component 412, the upper part, i.e., the second adapter component 414, is attached to the lower or internal part, i.e., on top of the first adapter component 412.

[0134] Figure 34 shows that the lower adapter component 412 is pushed into the outer adapter component 414 to an extent that the cannula does not penetrate the sealing plug 42. However, regardless of this, engagement has already occurred between the engaging hook, which is formed by the projections 423 and 425 that protrude radially inward from the tongue-shaped elements 416, 418, 420, and 424, and the first engaging recess 310.

[0135] Further diagrams show that both adapter parts 412 and 414 are pushed in further, in which case, as shown in Figure 38, the first adapter part 412 is pushed into the outer adapter part 414 to the extent that it is in close contact with the stopper 217 surrounding the outer adapter part 414, i.e., further pushing of each other is no longer possible. At this position, the cannula 50 penetrates the seal stopper 42 to the required extent. Next, the connector 52 is broken off, for example, to start the mixing process via the solvent bag hose. Of course, the stopper 217 is not necessarily required. More specifically, surrounding annular optical markings can also make it clear to the user that both adapter parts 412 and 414 have been pushed into each other to the extent necessary for the cannula 50 to penetrate the stopper 42 to a sufficient extent. [Examples]

[0136] It is necessary to refer to another emphasis-worthy embodiment of the embodiment shown in Figures 29-39. That is, there is a possibility that, for example, in a delivered state where the first, i.e., inner adapter part 412 is not yet enclosed in the vial, the first adapter part 412 is inserted into the second, i.e., outer adapter part 414 using its bottom side so that the tip of the cannula 50 is not grasped. The pushing is limited by engaging hooks, i.e., by engaging elements 416, 418, 420, 424 having engaging projections 423, 425. This ensures that the cannula 50 cannot penetrate the bottom of the first adapter part 412. In this case, the engaging hooks may have different lengths so that the bottom side of the adapter part 412 rests on the shorter hook. [Explanation of symbols]

[0137] 10 Connectors / Transfer Devices 12. First adapter part 14. Second adapter part 16 Circumferential wall / Outer wall 17, 19 Ribs 18 Bottom wall / bottom section 20 vials / bottles 22 Support elements / Annular elements / Annular sections 24 Protrusion 26 Protrusion 28 elements / fixed elements 30 elements / fixed elements 32 Long axis 34 The neck of the bottle 36 Cylindrical body 38 Connecting Walls / Transient Sections 40 Swelling 42 Stopper / Sealing stopper 44 Hollow cylindrical portion 46 Wall / Boundary Wall 48 Protrusion 50 Penetrating needles / cannulas 52 Break-off connectors 54 Inner wall 56 Recesses / Guides 58 Recess / Guide 60 portions 62 parts 64 Protrusion 66 Protrusion 68 Internal hollow cylindrical portion 70 Front edge 72 Protective elements 74 Cannula tip / tip 76 steps 78 ridges / angles 80 Terminal part 100 Connectors / Transfer Devices 112 First adapter part 114 Second adapter part 116 External hollow cylindrical portion 118 Internal hollow cylindrical portion 120 Intermediate wall 122 slits 124 Tongue / Element 126 Tongue / Element 128 Protrusion 130 External adapter parts 132 Internal hollow cylindrical portion 133 Ribs / Protrusions / Clamp Ribs 134 Second external hollow cylindrical portion 136 Third external hollow cylindrical portion 138 1st safety device 140 Intermediate wall 147 Protruding part / clamp rib 150 Side wall 152 steps 142 Front edge 144 parts 146 Safety equipment elements 148 Notches 153 Cut section 172 Protective elements 200 Connectors / Transfer Devices 212 Adapter parts 214 Adapter parts 216 Mantle Wall 217 Web / Protrusion 218 Bottom wall / bottom part 222 Ring elements / ring sections 223 Lingual elements 228 elements / fixed elements 230 elements / fixed elements 231 Another tongue-shaped element 244 Circumferential Wall 245 Boundary wall / Bottom wall 268 Internal hollow cylindrical portion 269 ​​Annular slit 270 Protrusion 310 Engaging recess / engaging notch 312 Engaging recess / engaging notch 314 elements 316 elements 318 elements 320 elements 322 Protrusion 324 Protrusion 326 ring elements 328 Periphery 330 Expansion section 332 Sealant 333 Circular uplift 400 Connectors / Transfer Devices 412 Adapter parts 414 Adapter parts 416 Lingual elements 418 Lingual elements 420 Lingual elements 423 Protrusion 424 Lingual elements 425 Protrusion 430 ring elements 432 Expansion section 434 Bottom wall 436 Sealant 438 Inner part 439 Vertical Rib 440 Peripheral portion 441 line 442 Circumferential Wall 444 Hollow cylindrical portion 446 Outer part 447 Protrusion

Claims

1. A transfer device (200) for removing or transferring a drug from or to a vial (20) having a vial neck (34) that can be sealed via a sealing stopper (42), said transfer device comprising: a first adapter part (212, 412) positionable on the vial; a second adapter part (214, 414) that interacts with the first adapter part and is movable in the longitudinal direction of the vial and has a transition element (50) for piercing the stopper; upon movement of the second adapter part (214, 414) along the first adapter part (212, 412) towards the stopper (42) and engagement of the second adapter part, a first interlocking element (314, 316, 318, 320, 416, 418, 420, 424) of the second adapter part interacts with a second interlocking element (310, 312) of the first adapter part, thereby non-releasably securing the first adapter part to the vial (20); The first adapter part (212, 412) includes a mantle wall (216) surrounding the vial (20) along its circumference, the mantle wall (216) having a hollow cylindrical shape and a front peripheral edge extending toward the sealing stopper side of the vial, and a bottom portion (218) at least partially covering the bottom of the vial; the second adapter part (214, 414) is sealed against the first adapter part when the second adapter part (214, 414) is in a position surrounding the first adapter part (212, 412); the second adapter part (214, 414) is provided with an inner hollow cylindrical sealing element (332, 436) which produces the sealing and is in close contact with the circumferential wall of the first adapter part, the sealing element being formed as an insert or as a lining in the cylindrical portion of the second adapter part, To provide an aerosol-tight seal when the vial is punctured, a transfer device in which a sealed space containing the vial is created before the transition element pierces the sealing stopper, and the first adapter part (212, 412) and the second adapter part (214, 414) are irreleasably fixed to each other while forming the sealed space by a first interlock element of the second adapter part and a second interlock element of the first adapter part interacting with each other.

2. A transfer device as described in claim 1, characterized in that when the transfer device (200) is fixed to the vial (20), the first and second adapter parts (212, 412, 214, 414) form a cover that completely surrounds the vial at least in the area of ​​the sealing stopper (42).

3. A transfer device as described in claim 1 or 2, characterized in that the first adapter part (212, 412) has a support portion located along the outer wall on the front peripheral side, from which extends a position fixing element (228, 230) which is formed in a tongue-like or web-like shape, which is mounted so that it can be bent or turned in the radial direction of the first adapter part, and which extends at an angle to the longitudinal axis (32) of the first adapter part.

4. A transfer device as described in claim 3, characterized in that the support portion has an annular portion (222) extending around the front peripheral region of the outer jacket wall, the annular portion extending partially along the inside of the outer jacket wall (216).

5. A transfer device as described in claim 4, characterized in that the annular portion has a first protrusion extending onto the front peripheral edge and being axially deformable.

6. A transfer device as described in claim 5, characterized in that the first protrusion extends from the annular portion.

7. A transfer device as described in any one of claims 1 to 6, characterized in that the second adapter part (214, 414) has an outer hollow cylindrical portion and a boundary wall (46) extending transversely to its longitudinal axis, and a puncture needle (50) exits from the boundary wall or is penetrated by the puncture needle.

8. A transfer device as described in claim 7, characterized in that an inner hollow cylindrical portion (268) extends coaxially to the outer hollow cylindrical portion (44) of the second adapter part (214, 414), a protective element is arranged in the inner hollow cylindrical portion, and when there is no connection of the first adapter part to the second adapter part, a tip (74) of the puncture needle (50) extends between the protective element and the boundary wall of the outer hollow cylindrical portion.

9. A transfer device as described in claim 3, characterized in that the tongue- or web-like position fixing element (228, 230) extending from the support portion extends in the direction of the bottom portion (218) of the first adapter part (212, 412) at an incline with respect to the longitudinal axis (32), and when the vial (20) is positioned in the first adapter part, the position fixing element is or can be supported by the vial or at a transition portion (38) between the vial neck (34) and the circumferential wall of the vial.

10. A transfer device as described in claim 3 or 7, characterized in that the inner cross-section of the outer hollow cylindrical portion of the second adapter part (214, 414) matches the outer cross-section of the outer jacket wall to guide the first adapter part (212, 412) during its axial movement.

11. A transfer device as described in any one of claims 1 to 10, characterized in that a stopper (217) protrudes from the outer wall (216) of the first adapter part (212, 412), and the second adapter part is in close contact with the stopper when the first and second adapter parts (212, 412, 214, 414) are connected.

12. A transfer device as described in any one of claims 1 to 11, characterized in that the first and second adapter parts (212, 412, 214, 414) form a sealed container surrounding the vial bottle (20) when the first and second adapter parts (212, 412, 214, 414) are at least partially engaged with each other.

13. A transfer device as described in any one of claims 1 to 12, characterized in that the internal hollow cylindrical portion (268) of the second adapter part (214, 414) has at least one protrusion (270) facing inwardly toward the end side, which protrusion engages with the bulging rim (40) of the vial bottle (20) from its rear side when both adapter parts (212, 412, 214) are connected.

14. A transfer device as described in claim 8, characterized in that the protective element is a disc element arranged to be axially movable.

15. A transfer device as described in any one of claims 1 to 14, characterized in that when the first adapter part and the second adapter part are engaged with each other, the two are irreleasably coupled during use.

16. A transfer device as described in any one of claims 1 to 15, characterized in that while the second adapter part (214, 414) changes position in the penetration direction of the puncture needle (50), the first adapter part (212, 412) interacts with the second adapter part such that a change in position of the second adapter part relative to the first adapter part in a direction opposite to the penetration direction is prevented.

17. The transfer device of claim 11, wherein the stopper is a surrounding annular protrusion (217).

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